ubrogepant (Rx)

Brand and Other Names:Ubrelvy
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 50mg
  • 100mg

Migraine

Indicated for acute treatment of migraine with or without aura

50-100 mg PO for acute migraine

If needed, may take second dose at least 2 hr after initial dose

Maximum dose: 200 mg/24 hr

Safety of treating >8 migraines/30-day period not established

Dosage Modifications

CYP3A4 inhibitors

Strong: Contraindicated

  • Moderate
    • Initial dose: 50 mg
    • Second dose (if needed): Avoid within 24 hr
  • Weak
    • Initial dose: 50 mg
    • Second dose (if needed): 50 mg

CYP3A4 inducers

Strong: Avoid concomitant use

  • Weak or moderate
    • Initial dose: 100 mg
    • Second dose (if needed): 100 mg

BCRP and/or P-gp only inhibitors

  • Initial dose: 50 mg
  • Second dose (if needed): 50 mg

Renal impairment

  • Mild or moderate (CrCl ≥30 mL/min): No dose adjustment required
  • Severe (CrCl 15-29 mL/min)
    • Initial dose: 50 mg
    • Second dose (if needed): 50 mg
  • End-stage renal disease (CrCl <15 mL/min)
    • Avoid

Hepatic impairment

  • Mild or moderate (Child-Pugh A or B): No dose adjustment required
  • Severe (Child-Pugh C)
    • Initial dose: 50 mg
    • Second dose (if needed): 50 mg

Dosing Considerations

Limitation of use: Not indicated for migraine prevention

Safety and efficacy not established

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Interactions

Interaction Checker

and ubrogepant

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            50 mg

            • Nausea (2%)
            • Somnolence (2%)

            100 mg

            • Nausea (4%)
            • Somnolence (3%)
            • Dry mouth (2%)

            <1%

            50 mg

            • Dry mouth
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            Warnings

            Contraindications

            Coadministration with strong CYP3A4 inhibitors

            Cautions

            Drug interaction overview

            • BCRP and/or P-gp only inhibitors: Ubrogepant dosage reduction recommended
            • CYP3A4 inhibitors
              • Contraindicated with strong CYP3A4 inhibitors
              • Ubrogepant dosage reduction recommended if coadministered with moderate or weak CYP3A4 inhibitors
            • CYP3A4 inducers
              • Avoid coadministration with strong CYP3A4 inducers
              • Ubrogepant dosage increase recommended if coadministered with moderate or weak CYP3A4 inducers
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            Pregnancy & Lactation

            Pregnancy

            Data are not available regarding risk associated with use in pregnant women

            Animal studies

            • Administration in rats during organogenesis resulted in no adverse effects on embryofetal development
            • Rabbits
              • Administration produced abortion and increased embryofetal mortality in surviving litters at high dose (250 mg/kg/day)
              • In a second study, excessive maternal toxicity at the high dose (250 mg/kg/day) resulted in early termination and lack of fetal data for that dose group

            Clinical considerations

            • Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy

            Lactation

            Data are not available regarding presence in human milk, effect on breastfed infants, or effects on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Highly potent, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist

            Human monoclonal antibody; binds to the CGRP receptor, which is thought to be causally involved in migraine pathophysiology

            Absorption

            Peak plasma time: 1.5 hr

            High-fat meal: Peak plasma time decreased by 2 hr and peak plasma concentration decreased by 22%

            Distribution

            Protein bound: 87%

            Vd: 350 L

            Metabolism

            Primarily metabolized by CYP3A4

            Metabolites: Glucuronide conjugate metabolites; not expected to contribute to pharmacological activity (6000-fold less potent than parent compound)

            Ubrogepant is a weak inhibitor of CYP2C8, 2C9, 2D6, 2C19, MAO-A, and UGT1A1

            Elimination

            Half-life: 5-7 hr

            Oral Clearance: 87 L/hr

            Excretion: Feces 42%; urine 6%

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            Administration

            Oral Administration

            Make take with or without food

            Storage

            Store at controlled room temperature of 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.